10 Hole Gridlock Helical Plate, Right

GUDID 00812926028514

TRILLIANT SURGICAL, LTD.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID00812926028514
NIH Device Record Key2a6463d5-54d3-4e50-a16c-6bd49a5307d7
Commercial Distribution StatusIn Commercial Distribution
Brand Name10 Hole Gridlock Helical Plate, Right
Version Model Number300-65-004
Company DUNS828829072
Company NameTRILLIANT SURGICAL, LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812926028514 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00812926028514]

Moist Heat or Steam Sterilization


[00812926028514]

Moist Heat or Steam Sterilization


[00812926028514]

Moist Heat or Steam Sterilization


[00812926028514]

Moist Heat or Steam Sterilization


[00812926028514]

Moist Heat or Steam Sterilization


[00812926028514]

Moist Heat or Steam Sterilization


[00812926028514]

Moist Heat or Steam Sterilization


[00812926028514]

Moist Heat or Steam Sterilization


[00812926028514]

Moist Heat or Steam Sterilization


[00812926028514]

Moist Heat or Steam Sterilization


[00812926028514]

Moist Heat or Steam Sterilization


[00812926028514]

Moist Heat or Steam Sterilization


[00812926028514]

Moist Heat or Steam Sterilization


[00812926028514]

Moist Heat or Steam Sterilization


[00812926028514]

Moist Heat or Steam Sterilization


[00812926028514]

Moist Heat or Steam Sterilization


[00812926028514]

Moist Heat or Steam Sterilization


[00812926028514]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-15
Device Publish Date2018-10-15

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